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Clinical Trials/NCT06251687
NCT06251687
Recruiting
Not Applicable

Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis:a Multicenter Prospective Study

China-Japan Friendship Hospital1 site in 1 country100 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Fibrosis
Sponsor
China-Japan Friendship Hospital
Enrollment
100
Locations
1
Primary Endpoint
the diagnostic performance of transbronchial cryobiopsy(TBLC)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this clinical study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy(TBLC)in progressive pulmonary fibrosis. The main question it aims to answer are: • Determine the prognosis, health economics, and therapeutic strategy changes of patients with TBLC retrograde malleable pulmonary fibrosis. Participants will be randomly divided into two groups, and received TBLB or TBLC.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
China-Japan Friendship Hospital
Responsible Party
Principal Investigator
Principal Investigator

Gang Hou

Principal Investigator

China-Japan Friendship Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.

Exclusion Criteria

  • Patients with platelet counts below 50,000×109/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC

Outcomes

Primary Outcomes

the diagnostic performance of transbronchial cryobiopsy(TBLC)

Time Frame: 1 month after transbronchial cryobiopsy

the sensitivity and specificity of transbronchial cryobiopsy(TBLC)in suspected progressive pulmonary fibrosis

Secondary Outcomes

  • the safety of transbronchial cryobiopsy(TBLC)(7 days and 1 month after transbronchial cryobiopsy)

Study Sites (1)

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